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ShopRite Infants Simethicone

Medically reviewed on September 4, 2018

Dosage form: emulsion
Ingredients: SIMETHICONE 20mg in 0.3mL
Labeler: Wakefern Food Corporation
NDC Code: 41190-882

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ShopRite Infants’ Simethicone Drops Drug Facts

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Warnings

When using this product

do not exceed 12 doses per day

Keep out of reach of children.

Directions
shake well before using
all dosages may be repeated as needed, after meals and at bedtime
fill enclosed dropper to recommended dosage level
dispense liquid slowly into baby’s mouth, toward the inner cheek
may mix with 1 oz. of cool water, infant formula or other suitable liquids
clean dropper after each use and replace original cap

age (yr)

weight (lb)

dose

infants under 2

under 24

0.3 mL

children over 2

over 24

0.6 mL

Other information

store at room temperature (59°-86°F)

Inactive ingredients

citric acid, flavor, hypromellose, maltitol, methylcellulose, mono- and di- glycerides, polyethylene glycol, polyethylene glycol stearate, polysorbate 65, purified water, sodium benzoate, sodium citrate, sorbic acid, xanthan gum

Questions or comments?

1-800-SHOPRITE

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Compare to: Active Ingredient in Infants’ Mylicon® Drops

Infants’

SIMETHICONE DROPS

SIMETHICONE 20 mg

ANTI-GAS

Gas Relief

Non-Staining

No Alcohol

No Saccharin

No Artificial Flavor

No Artificial Colors

Dosage Dropper Enclosed

1 FL OZ (30mL)

SHOPRITE INFANTS SIMETHICONE 
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-882
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CITRIC ACID MONOHYDRATE 
HYPROMELLOSES 
MALTITOL 
POLYETHYLENE GLYCOLS 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBIC ACID 
XANTHAN GUM 
POLYSORBATE 65 
Product Characteristics
ColorWHITE (white to off white, opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41190-882-101 BOTTLE in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33206/16/2013
Labeler - Wakefern Food Corporation (069722418)

 
Wakefern Food Corporation

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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